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PARACHUTE: A Multinational Trial To Evaluate The Parachute Implant System

Sponsor
CardioKinetix, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT01286116
Collaborator
(none)
59
Enrollment
13
Locations
1
Arm
73
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.

Condition or Disease Intervention/Treatment Phase
  • Device: Parachute Implant
 Phase 3

Detailed Description

While current therapies for heart failure (including but not limited to: medical management, cardiac resynchronization and ICDs) may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device. The purpose of this study is to assess the safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of the left ventricle in patients with symptoms of HF due to ischemic heart disease.

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A MULTINATIONAL TRIAL TO EVALUATE THE PARACHUTE IMPLANT SYSTEM: PARACHUTE PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Parachute implant

Device: Parachute Implant
Mechanical ventricular partitioning

Outcome Measures

Primary Outcome Measures

  1. The successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE) [6-months]

    Assessment of safety defined as the successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device.

Secondary Outcome Measures

  1. Change in Left Ventricular Volume Indexes. [6 months]

    Change in Left Ventricular Volume Indexes including End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Candidates for this study must meet ALL of the following inclusion criteria:

  1. Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region

  2. Subject is not hospitalized at time of enrollment.

  3. Diagnosis of heart failure for a minimum of 6 months prior to enrollment

  4. NYHA Class at time of enrollment, either:

  • NYHA Class III or Ambulatory IV - if predominant during the 3-month period prior to enrollment

  • NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment

  1. LVEF >15% and ≤ 40% as measured by echocardiography.

  2. Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.

  3. Eligible for cardiac surgery

  4. Between 18 and 79 years of age (inclusive)

  5. Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2009 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment

  6. Female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study

  7. Provide written informed consent

  8. Agree to the protocol-required follow-up

Exclusion Criteria:
Candidates will be excluded from the study if ANY of the following conditions apply:

  1. Untreated clinically significant coronary artery disease requiring intervention.

  2. Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment

  3. Cardiogenic shock within 72 hours of enrollment

  4. Revascularization procedure (PCI or CABG) within 60 days of enrollment

  5. Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment

  6. Moderate aortic stenosis and regurgitation (aortic or mitral) >2+.

  7. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF

  8. A known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.

  9. Aortic valve replacement or repair

  10. Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.

  11. Active peptic ulcer or GI bleeding within the past 3 months

  12. Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months

  13. History of Kawasaki's disease

  14. Patient has received a heart, lung, liver and/or kidney transplant

  15. Patient on dialysis or expected to require hemodialysis within 12 months

  16. Patient has chronic liver disease

  17. Impaired renal function that places patient at risk of contrast induced renal failure

  18. Ongoing sepsis, including active endocarditis.

  19. Co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)

  20. Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of Cardiology Louis Pradel (Lyon) Bron France 69500
2 Institut Cardiovasculaire Paris-Sud Massy France 91300
3 University of Heidelberg Heidelberg Germany 69120
4 Universitat Rostock Rostock Germany 18057
5 Pauls Stradins Clinical University Hospital Riga Latvia LV1002
6 University of Amsterdam AMC Amsterdam Netherlands 1005 AZ
7 Hospital Santa Marta Lisbon Portugal 1169-024
8 Centro Hospitalar de Vila Nova de Gaia Vila Nova de Gaia Portugal 4430-502
9 Clinical Center of Serbia (KCS) Belgrade Serbia 11000
10 Ljubljana University Medical Center (Univerzitetni Klinicni Center Ljubljana) Ljubljana Slovenia 1525
11 Papworth Hospital Cambridge United Kingdom CB23 3RE
12 St. Thomas' Hospital London United Kingdom SE1 7EH
13 University College of London (The Heart Hospital) London United Kingdom W1G 8PH

Sponsors and Collaborators

  • CardioKinetix, Inc

Investigators

  • Principal Investigator: Martyn Thomas, MD, St. Thomas' Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CardioKinetix, Inc
ClinicalTrials.gov Identifier:
NCT01286116
Other Study ID Numbers:
  • VA0444
First Posted:
Jan 31, 2011
Last Update Posted:
Jun 23, 2017
Last Verified:
Jun 1, 2017
Keywords provided by CardioKinetix, Inc
heart failure
percutaneous
interventional cardiology
apical remodeling
LV dilatation
akinesis
dyskinesis
myocardial infarction
Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Jun 23, 2017